(88 days)
The LuminScan(TM) Imaging System is is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two dimensional, cross sectional, real-time depth visualization.
LuminScan™ Imaging System is a general imaging system comprised of LuminScan™ Imaging System Console and LuminScan™ Disposable Imaging Kit.
The provided document is a 510(k) Summary for the LuminScan™ Imaging System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing comprehensive clinical study data for new claims.
Based on the provided text, the following information can be extracted regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states, "all the tests were found to be within their test acceptance criteria (passing test result)" for the Disposable Imaging Kit testing, System Performance Testing, and Reliability Testing. However, specific numerical acceptance criteria (e.g., minimum values, ranges, tolerances) are not detailed in the provided text. The tables only list the tests performed and a general "passing test result."
| Test Category | Specific Test | Acceptance Criteria (Not Detailed) | Reported Device Performance |
|---|---|---|---|
| Disposable Imaging Kit Testing | Balloon Diameter | Within specified range | Passing test result |
| Balloon Length | Within specified range | Passing test result | |
| Balloon Burst Testing | Withstood specified pressure | Passing test result | |
| Balloon Fatigue Testing | Withstood specified cycles | Passing test result | |
| Balloon Inflation/Deflation Testing | Within specified time | Passing test result | |
| Tensile Strength | Met specified strength | Passing test result | |
| Endoscopic Compatibility Testing | Compatible with specified endoscopes | Passing test result | |
| Airtightness | Maintained airtight seal | Passing test result | |
| Retraction Testing | Retracted as specified | Passing test result | |
| Sterilization and Shelf Life Testing | Met sterility and shelf-life requirements | Passing test result | |
| Biocompatibility Testing | Met ISO 10993 requirements | Passing test result | |
| Reliability Testing | Environmental Factors | Maintained performance under specified conditions | Passing test result |
| Vibration Testing | Maintained performance after vibration | Passing test result | |
| System Performance Testing | High-level product design requirements | Met specified requirements | Passing test result |
| Animal Testing (Image Quality) | Evaluation of imaging procedure and image quality | Device meets design requirements as intended | Images captured, reviewable, zoomable, markable, snapshot function operational |
2. Sample Size Used for the Test Set and Data Provenance:
- Disposable Imaging Kit Testing: The specific sample sizes for each individual test (e.g., balloon burst, tensile strength) are not provided.
- Reliability Testing: The specific sample sizes for environmental and vibration testing are not provided.
- System Performance Testing: The specific sample size is not provided.
- Animal Testing: The sample size was 2 Bama miniature pigs (one male, one female). The provenance is implied to be internal testing by Micro-Tech (Nanjing) Co., Ltd., which is located in Nanjing, China. This was a prospective animal study as part of the device evaluation.
- No clinical performance data (human studies) was included in this 510(k) submission. Therefore, there is no human test set or data provenance mentioned for clinical performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- No human "test set" in the context of clinical images with expert-established ground truths is mentioned. The submission explicitly states: "This section is not applicable because there is not including any clinical performance data with this 510(k) Submission."
- For the animal testing, the "ground truth" was the in vivo imaging procedure itself and the assessment of image quality against design requirements. The document does not specify the number or qualifications of experts who evaluated the animal images.
4. Adjudication Method for the Test Set:
- Not applicable as no clinical performance data with human test sets and expert adjudication is presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The submission states "there is not including any clinical performance data with this 510(k) Submission." Thus, no comparison of human readers with or without AI assistance was performed or reported here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:
- The LuminScan™ Imaging System is described as an "imaging tool" to provide 2D, cross-sectional, real-time depth visualization. It is an Optical Coherence Tomography (OCT) device, which generates images for human interpretation, not an AI algorithm that provides automated diagnoses or standalone performance metrics. Therefore, a standalone algorithm-only performance study as typically understood for AI/ML devices is not applicable here. The "System Performance Testing" and "Animal Testing" were likely evaluations of the device's ability to produce clear images suitable for human interpretation and meet its specified imaging capabilities.
7. The Type of Ground Truth Used:
- For the technical performance tests (Disposable Imaging Kit, Reliability, System Performance): The ground truth was based on engineering specifications, recognized standards (e.g., ISO, IEC), and design requirements.
- For animal testing: The "ground truth" was the visual assessment of the captured two-dimensional and cross-sectional OCT images of the animal esophagus, ensuring they met the device's design requirements for imaging procedure and image quality. This is an observational, expert-evaluated ground truth against technical specifications.
8. The Sample Size for the Training Set:
- The LuminScan™ Imaging System is an OCT imaging device, not explicitly an AI/ML-driven diagnostic algorithm that typically relies on large training datasets for image interpretation. While it contains software, the 510(k) summary classifies it as having a "Minor" level of concern for software failures, implying its primary function is image acquisition and display rather than complex automated analysis requiring extensive image training sets. Therefore, a "training set" in the context of machine learning is not discussed or specified in this document.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set for a machine learning algorithm is mentioned or implied by the device's description in this submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 29, 2016
Micro-Tech (Nanjing) Co., Ltd. Ms. Becky Li Quality Director No. 10 Gaoke Third Road Nanjing National Hi-Tech, Industrial Development Zone Nanjing, 210032 CN
Re: K162466
Trade/Device Name: LuminScan™ Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NQQ Dated: August 31, 2016 Received: September 2, 2016
Dear Ms. Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
LuminScan(TM) Imaging System
Indications for Use (Describe)
The LuminScan(TM) Imaging System is is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two dimensional, cross sectional, real-time depth visualization.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows a logo for Micro-Tech. The logo consists of a blue 3D block letter "MT" on the left, and the text "MICRO-TECH" on the right. Below the text "MICRO-TECH" are two Chinese characters.
510K Summary
510 (K) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: _
510 (K) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: __
-
- Date of Preparation: 11/24/2016
-
- Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, 210032, Jiangsu Province, PRC Establishment Registration Number: 3004837686 Contact Person: Becky Li Position: Quality Director Tel: +86-25-58646378 Fax: +86-25-58744269 Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Product Name: LuminScan™ Imaging System Common Name: Endoscopic Optical Coherence Tomography Imaging System (EOCT Imaging System) Model: C1 Regulatory Information: Classification Name: Ultrasonic pulsed echo imaging system Classification: Class II Product Code: NQQ Regulation Number: 21 CFR892.1560 Review Panel: General & Plastic Surgery
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Image /page/4/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font. The letters are blue and appear to be made of blocks. To the right of the letters is the word "MICRO-TECH" in a simple, sans-serif font. Below the word "MICRO-TECH" are two Chinese characters.
4. Identification of Predicate Device
510(k) Number: K112770
Product Name: Nvision VLE Imaging System (OCT)
5. Device Description
LuminScan™ Imaging System is a general imaging system comprised of LuminScan™ Imaging System Console and LuminScan™ Disposable Imaging Kit.
6. Indications for Use
LuminScan™ Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two dimensional, cross sectional, real-time depth visualization.
7. Clinical Test Conclusion
This section is not applicable because there is not including any clinical performance data with this 510(k) Submission.
8. Comparison of Technological Characteristics
LuminScan™ Imaging System is an optical coherence tomography (OCT) imaging device, which has similar technological characteristics as the predicate device cleared under 510(k) K112770 of NinePoint Medical Inc. Both devices use the principles of swept source OCT to generate high-resolution, two-dimensional, cross-sectional images of tissue microstructures in real time.
The main technological differences between the proposed device and the predicate device are the inflation method of accessory and the parameters of the accessory. The proposed device use automatic pump to inflate balloon of accessory, and controlled by system software. The predicate device use manual method to inflate balloon. In additional, the diameter of the inflation balloon in the proposed device is 16 mm whereas the diameter in the predicated device is 25 mm. Moreover, the inflated pressure of the inflation balloon in the proposed device is 3 atm whereas the pressure in the predicate device is 0.34 atm. Furthermore, the accessory in the proposed device can pass through the endoscopic channel as small as 2.8 mm. The predicate device
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requires an endoscopic channel of no less than 3.7 mm.
With risk mitigation mechanisms in the proposed device, however, these differences
between the proposed device and the predicate device in the technological
characteristics are minor and would not raise any questions of safety or effectiveness.
Comparison to predicate Device:
| TechnologicalCharacteristics | Nvision VLE® Imaging System(K112770) | LuminScan™ Imaging System |
|---|---|---|
| Intended Use and compatibility: | ||
| Product Code | NQQ | NQQ |
| Regulation No. | 21CFR892.1560 | 21CFR892.1560 |
| Class | 2 | 2 |
| Supplied Sterile | Yes | Yes |
| Configuration | Imaging tool and accessory | Imaging tool and accessory |
| Where Used | Hospital Setting | Hospital Setting |
| Indications for Use | Imaging tool in the evaluation ofhuman tissue microstructure byproviding two-dimensional ,crosssectional , real- time depthvisualization | Imaging tool in the evaluation ofhuman tissue microstructure byproviding two-dimensional ,crosssectional , real- time depthvisualization |
| Console: | ||
| Radiation Type | Near Infrared | Near Infrared |
| Optical Source | Swept source laser | Swept source laser |
| Center Wavelength | 1300 nm | 1300 nm |
| Optical Bandwidth | 110 nm | 120 nm |
| Optical RadiationSafety | Safe for indicated use, Class 1Mlaser source | Safe for indicated use, Class 1Mlaser source |
| MeasurementTechnique | OCT, Fourier domain | OCT, Fourier domain |
| Scanning Mode | Helical pitch (360 degree + 6 cmpullback length) | Helical pitch (360 degree, up to 8cm pullback length) |
| Frame Rate | 12.5 frames/sec | 24.4 frames/sec |
| Inflation Method | manual | automatic |
| Optical Probe: | ||
| Optical Fiber ProbeMaterial | Silica and borosilicate glass | Silica and borosilicate glass |
| Torque Cable andHypo tube CapMaterial | 316 SS | 304 SS |
| Optical Probe | Single mode optical fiber with distaloptics | Single mode optical fiber with distaloptics |
| 510K Summary | ||
| TechnologicalCharacteristics | Nvision VLE® Imaging System(K112770) | LuminScan™ Imaging System |
| Probe Dimensions | 2.5 m nominal | 2.5 m nominal |
| Guide Sheath: | ||
| Shaft Material | Nylon | Nylon |
| Balloon Material | PET | Nylon |
| Guide Sheath | Balloon guide sheath , polymertubing with closed end | Balloon guide sheath , polymertubing with closed end |
| Inflated Diameter | 25 mm | 16 mm |
| Inflated Length | 72 mm | 30/55/80 mm |
| Inflated Pressure | 5 psi (0.34 atm) | 3 atm |
| Sheath Assemblywill be Inflated andDeflated MultipleTimes | >10 cycles | >20 cycles |
| Balloon Inflationand Deflation Time | <60 sec | <60 sec |
| EndoscopicChannel | 3.7mm | ≥2.8 mm |
| Tip structure | Atraumatic tip | Atraumatic tip |
| Biocompatibility(Body contactingcomponents) | ISO 10993 compatible | ISO 10993 compatible |
| General Use | Single use and sterile guide sheathand optical probe | Single use and sterile guide sheathand optical probe |
| Shelf life | 6 months | 12 months |
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Image /page/6/Picture/0 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue, three-dimensional font on the left. To the right of the letters is the text "MICRO-TECH" in a simple, sans-serif font, also in blue. Below the text "MICRO-TECH" are two Chinese characters.
9. Performance Data
Safety Testing
The product development processes have been shown to conform to product safety
| Safety Testing | Recognized Standard or Guidance |
|---|---|
| Risk Management | ISO 14971 |
| Medical Electrical Equipment | IEC 60601-1 |
| Electromagnetic Compatibility | IEC 60601-1-2 |
| Application of Usability | IEC 60601-1-6 and IEC62366 |
| Safety of Endoscopic Equipment | IEC 60601-2-18 |
| Laser Safety | IEC 60825-1 |
| Biological Evaluation Of Medical Devices -Ethylene Oxide Sterilization Residuals | ISO 10993-7 |
| Validation and Routine Control of EthyleneOxide Sterilization process | ISO 11135-1 |
standard including:
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| Safety Testing | Recognized Standard or Guidance |
|---|---|
| Transport Packaging | ISTA 2A and 2B |
510K Summary
Bench Testing
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for the LuminScan™ Imaging System was considered as a "Minor" level of concern, since failures or latent design flaws in the software are unlikely to cause any injury to the patient or operator.
Disposable Imaging Kit Testing
The following in-vitro performance tests were completed on the Disposable Imaging
Kit; all the tests were found to be within their test acceptance criteria (passing test
result):
| Balloon Diameter | Balloon length |
|---|---|
| Balloon Burst Testing | Balloon Fatigue Testing |
| Balloon Inflation/Deflation Testing | Tensile Strength |
| Endoscopic Compatibility Testing | Airtightness |
| Retraction testing | Sterilization and Shelf Life Testing |
| Biocompatibility Testing |
Reliability Testing
Device reliability was evaluated against several environments factors (e.g., temperature, humidity) when the product was in operation or was properly stored. In additional, vibration testing was performed to evaluate the device reliability when the product was power off. Both tests yielded passing results.
System Performance Testing
High-level product design requirements of the LuminScan™ Imaging System were evaluated in system performance testing. System performance yielded a passing test result.
Animal Testing
Animal testing was performed to evaluate imaging procedure as well as image quality
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to ensure that the device meets the design requirements as intended.
An animal testing summary is provided in the following table:
| Item | Description |
|---|---|
| Species | Bama miniature pig ( Sus scrofa domesticus ) |
| Quantity | 2 |
| Sex | One male and one female |
| Age | 8-9 months |
| Weight | 35-40 kg |
| Imaging Anatomical Area | Esophagus |
| Obtained Images | Two-dimensional and cross-sectional OCT images of animalesophagus were captured by the device. User could review theimages with replay function. User could select region of interest(ROI) on the cross-sectional images and show zoomed-in imageof ROI. User could make marker on the images and take asnapshot of it. |
10. Substantially Equivalent (SE) Conclusion
Third Party safety testing, adherence to U.S. FDA design control guidance and ISO 14971, as well as thorough in-house, non-clinical (bench) testing and software validation provide reasonable assurance that the LuminScan™ Imaging System is safe and effective, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device, the Nvsion VLE Imaging System under K112770.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.